At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Pharmaceutical Process Operations
Job Category: Professional
All Job Posting Locations: Ringaskiddy, Cork, Ireland
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for the Manufacturing Process Specialist (MPS) role to be in Cork, Ireland.
Purpose:
The manufacturing process specialist will be responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within operations.
You will be responsible for:
* Representing Operations on cross functional project implementation teams.
* Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
* Monitoring and reporting of process performance using statistical process control.
* Troubleshooting of DCS (e.g Delta V) and PLC control systems.
* Preparation and updating of Batch Records, Procedures and Work Instructions.
* Providing process and equipment related training as required within the Manufacturing Department.
* Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
General Scope of Responsibilities:
* Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behaviour in every activity.
* Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
* Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
* Compliance with Manufacturing and general site procedures at all times and completion of all documentation in compliance with site procedures and GDP.
* Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
* Lead and Support investigation and resolution of problems on plant and participate in and lead Cross-Functional teams as necessary.
* Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
* Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group.
* Support ongoing studies by Validation, OTS, and other support functions.
Leadership Responsibilities / Individual Contribution:
* Be familiar with daily activities in manufacturing.
* Facilitate an environment of continuous improvement and open communication.
* Lead investigations in work area as necessary.
* Collaboration and teamwork.
* Initiative and motivation.
* Share ideas and suggestions for improvement and encourage others to do the same.
* Interface with all site departments, Operations and Maintenance.
* Contact with Engineering, Quality, Logistics, OTS, Validation and Training departments. Contact with other Janssen Biologics sites.
* Be conscious of internal customers to Manufacturing department and be cognoscente of their requirements.
Qualifications / Requirements:
* Minimum bachelor’s degree in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
* Manufacturing experience within a GMP regulated environment.
* Experience of the cell culture or purification processes.
* Project / New equipment installation experience.
* Process engineering experience.
Desirable:
* Commissioning and qualification experience.
* Experience of Microsoft Word, Excel and Outlook.
* Experience of DCS (e.g. Delta V), SCADA and PLC systems.
* Experience of SAP, LIM’s and/or other business systems.
* 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
* Ability to operate as part of a team with attention to detail.
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